Sections in this article
- Vaccines Overview
- Vaccine Product Type
- Preparing Vaccine Submissions
Vault Safety supports processing and preparing submissions for adverse events in relation to a vaccine product. This support is provided through the Vaccine product type, regional fields, and E2B formats.
Vaults originally deployed in 20R2 or an earlier release require configuration to enable vaccine product types and data capture. The vaccine feature enablement instructions provide more information.
For electronic submissions directly from Vault Safety, an administrator must configure the electronic gateway settings. The following pages provide more information:
Vaccine Product Type
Once the Vaccine product type is made active, Administrators can configure a Vaccine-type Product in Business Admin.
Case intake and processing users can then select that Vaccine-type Product when they add a product to an AER or Case. The Vaccine object type is available for the Product, Study Product, and Case Product objects.
Preparing Vaccine Submissions
Vault Safety supports generating vaccine ICSR submissions using E2B formats. The following pages provide general information on generating reports and preparing submissions:
The following sections provide more information on preparing vaccine submissions to various health authorities.
Global Vaccine Submissions
Vault Safety supports generating ICH-compliant E2B files using the (R2) or (R3) format.
EMA VAERS Submissions
Vaccine submissions to the EMA should use the following settings:
- The EMA E2B (R3) document type and file format
- The EU EMA EV Gateway and Transmission Profile
EMA E2B (R3) specifications do not have regional fields for vaccines.
FDA VAERS Submissions
Vaccine submissions to the FDA should use the following settings:
- The FDA VAERS E2B (R3) document type and file format
- The US FDA CBER VAERS Gateway and FDA CBER VAERS Profile Transmission Profile
Vault Safety is compliant with the ten (10) VAERS submission scenarios, described on the FDA website.
The FDA VAERS E2B (R3) tab on the E2B Generation Data Mapping page provides detailed information on how the system generates each of the regional FDA VAERS fields.
FDA VAERS Acknowledgments
Vault Safety supports exchanging the three types of VAERS automated acknowledgment messages (ACKs). When Vault Safety receives an ACK, it is attached to the Submission record. Troubleshoot FDA Gateway Submissions provides more information on MDNs and ACKs.
The following table describes each VAERS ACK and the corresponding Vault Safety ACK:
|Vault Safety ACK||VAERS ACK||Description|
|ACK1||-||Establishing connection between the origin and destination gateway|
|ACK2||VAERS ACK1||FDA Message Delivery Notification (MDN) status
When this ACK is received, the Submission record is updated to the appropriate lifecycle state (MDN Received or MDN Failure)
|ACK3||VAERS ACK2||Center acceptance/FDA Receipt Date|
|ACK4||VAERS ACK3||FDA AE Program-Level Acknowledgment
When this ACK is received, the Submission record is updated to the appropriate lifecycle state (E2B ACK Accepted, E2B ACK Rejected, or E2B ACK Warning)
FDA VAERS Regional Units of Measurement
Vault Safety ensures that only units of measurements and the appropriate codes supported by FDA VAERS are exported in the FDA VAERS E2B (R3) file format.
Tip If a Case contains a unit of measurement that is not supported by FDA VAERS, the system does not export the field and sends an email and vault notification to the user who initiated the file generation.
Users with access to the Admin area can view these units in Business Admin > Agency Units of Measurement.
FDA VAERS Regional Fields
Note The FDA regional fields are not added to page layouts by default. An administrator must configure your vault to display these fields.
Vault Safety includes vaccine-related regional fields to support FDA VAERS submissions.
Tip If masked distributions are configured, the system masks sensitive VAERS E2B data elements in the generated file.
The following sections give an overview of how the system captures FDA regional data for VAERS.
Additional Patient Information
The following list describes how the system captures additional patient information for FDA VAERS:
- Patient Contact Information — The Patient-type Case Contact captures patient contact information for FDA VAERS submissions. You cannot create more than one Patient Case Contact. Patient Contact is created on every Case where the patient is not a primary reporter.
- Additional Personal Information — The following Patient fields on the Case object capture additional patient information.
- Patient Prefix
- Patient First Name
- Patient Middle Name
- Patient Last Name
- Age at Vaccination
- Military Status
- Ethnicity (Reason Omitted)
- Race (Reason Omitted)
- Vaccine-related Pregnancy Field — The Pregnant at Exposure field on the Case object captures information about pregnancy and vaccination.
Parent Age at Vaccination
The Age at Vaccination field is available for Parent-type Cases. This field is auto-calculated on Study Cases with Vaccine Study Products.
Vaccine Product Information
The Vaccine Type field is available for Vaccine-type Case Products.
The Similar Device Controlled Vocabulary for the Drug Role field is also available to inform the FDA about additional US-marketed products having the same or similar device (FDA G.k.1.a) as the primary vaccine combination product for which a malfunction is being reported.
Vaccine Drug History
The following fields are available to capture vaccine drug history information:
- Product Type
- Age at Vaccination
Vaccines (Past 4 Weeks)
The system looks at all Vaccine-type Case Products to determine whether any vaccines were given within 4 weeks of the suspect product, based on the latest dose recorded for each Case Product.
The following fields are available for Vaccine-type Case Product Dosages:
- Administration Facility
- Anatomical Site
- Dose Number in Series
Illness at Vaccination
The Illness at Vaccination field is available on the Case Medical History object. When this field is set to “Yes”, the illness information is included in a separate section in the E2B transmission message. When this field is set to “No”, the illness information is included in the Medical History section.
Adverse Event Hospitalization Details
The following fields are available to capture details about vaccine adverse events that resulted in hospitalization or treatment:
- Reaction Identifier
- Hospitalization Required
- Number of days hospitalized
- Hospital Name
- Resulted in Prolongation of Hospitalization
- Emergency room/department or urgent care
- Doctor/healthcare professional office
- Outcome: None of the Above
The Facility-type Case Contact captures contact information for the facility where the vaccine was administered. You can add a Facility record from the Case, and then reference the Facility from a Case Product Dosage record using the Administration Facility field.
Health Care Professional
The Health Care Professional-type Case Contact captures contact information for the health care professional who treated the patient for the adverse event that resulted in hospitalization or treatment.
VAERS Best Doctor
The best doctor field designates a health care professional (or reporter) as the best point of contact. You can only have one Health Care Professional Case Contact designated as the Best Doctor.
Additional Reporter Contact Information
The following fields capture additional reporter contact information for VAERS:
- Street Line 2
Patient and Parent values are added as additional options in the Reporter Qualification field. These values are added in the deprecated state by default and must be set to Active by an administrator.
The Patient option impacts how Case Contacts are automatically created and updated. For more information, see How Case Contacts are Automatically Created and Updated.